The Interplay of Perceived Risks and Benefits in Deciding to Become Vaccinated against COVID-19 While Pregnant or Breastfeeding: A Cross-Sectional Study in Italy.

The present study examined the role of the perception of risks and benefits for the mother and her babies in deciding about the COVID-19 vaccination. In this cross-sectional study, five hypotheses were tested using data from a convenience sample of Italian pregnant and/or breastfeeding women (N = 1104, July-September 2021). A logistic regression model estimated the influence of the predictors on the reported behavior, and a beta regression model was used to evaluate which factors influenced the willingness to become vaccinated among unvaccinated women. The COVID-19 vaccination overall risks/benefits tradeoff was highly predictive of both behavior and intention. Ceteris paribus, an increase in the perception of risks for the baby weighed more against vaccination than a similar increase in the perception of risks for the mother. Additionally, pregnant women resulted in being less likely (or willing) to be vaccinated in their status than breastfeeding women, but they were equally accepting of vaccination if they were not pregnant. COVID-19 risk perception predicted intention to become vaccinated, but not behavior. In conclusion, the overall risks/benefits tradeoff is key in predicting vaccination behavior and intention, but the concerns for the baby weigh more than those for the mother in the decision, shedding light on this previously neglected aspect.

Acute appendicitis in a patient immunised with COVID-19 vaccine: A case report with morphological analysis.

Although the benefit/risk profile for mRNA COVID-19 vaccines is recognised as extremely favourable, appendicitis is currently considered an adverse event (AE) of special interest. We describe the case of a 58-year-old female who presented with signs and symptoms of appendicitis approximately 48 hours after her first injection of the Pfizer-BioNTech vaccine. Abdominal ultrasound revealed fluid collection in the right iliac fossa and cecal wall thickening. Following the surgical visit, CT scan with contrast showed a distended appendix with thickened walls, suggestive of acute appendicitis. The patient tested negative to upper respiratory COVID-19 reverse transcription-polymerase chain reaction. Clinical trials and observational studies suggest a possible association between appendicitis and COVID-19 vaccines. Th-1 driven granulomatous inflammation reported in our case represents an infrequent nonspecific chronic inflammation of the appendix, especially in the setting of delayed or interval appendectomy. In view of the current paediatric vaccination campaign, we recommend monitoring the safety profile and potential gastrointestinal AEs associated with mRNA COVID-19 vaccines to swiftly manage subjects with gastrointestinal symptoms and prevent potential complications.

Exposures and Suspected Intoxications to Pharmacological and Non-Pharmacological Agents in Children Aged 0-14 Years: Real-World Data from an Italian Reference Poison Control Centre.

This study describes the exposures and suspected intoxications in children (0-14 years) managed by an Italian reference poison control center (PCC). A seven-year observational retrospective study was performed on the medical records of the Toxicology Unit and PCC, Careggi University Hospital, Florence (Italy). During the study period (2015-2021), a total of 27,212 phone call consultations were managed by the PCC, of which 11,996 (44%) involved subjects aged 0-14 years. Most cases occurred in males (54%) aged 1-5 years (73.8%), mainly at home (97.4%), and with an oral route of intoxication (93%). Cases mainly occurred involuntarily. Consultations were generally requested by caregivers; however, in the age group 12-14 years, 70% were requested by healthcare professionals due to voluntary intoxications. Cleaners (19.44%) and household products (10.90%) were the most represented suspected agents. Pharmacological agents accounted for 28.80% of exposures. Covariates associated with a higher risk of emergency department visit or hospitalization were voluntary intoxication (OR 29.18 [11.76-72.38]), inhalation route (OR 1.87 [1.09-3.23]), and pharmacological agents (OR 1.34 [1.23-1.46]), particularly central nervous system medications. Overall, consultations do not burden national and regional healthcare facilities, revealing the activity of PCCs as having a strategic role in reducing public health spending, even during the COVID-19 pandemic.

The value of public-private collaborative real-world evidence platforms to monitor vaccine performance post authorization: DRIVE - a European initiative.

INTRODUCTION: Fighting pandemics requires an established infrastructure for pandemic preparedness, with existing, sustainable platforms ready to be activated. This includes platforms for disease surveillance, virus circulation, and vaccine performance monitoring based on Real-World data, to complement clinical trial evidence. AREAS COVERED: Because of its complexity, this can best be done by combining efforts between public and private sectors, developing a multi-stakeholder approach. Public-Private-Partnerships increasingly play a critical role in combating infectious diseases but are still looked at with hesitancy. The Development of Robust and Innovative Vaccine Effectiveness (DRIVE) project, which established a platform for measuring brand-specific influenza vaccine effectiveness in Europe, exemplifies how to build a collaborative platform with transparent governance, state-of-the-art methodology, and a large network of participating sites. Lessons learned from DRIVE have been cardinal to set up COVIDRIVE, a platform for brand-specific COVID-19 vaccine effectiveness monitoring. EXPERT OPINION: The DRIVE partners propose that a debate on the benefits of Public-Private-Partnership-generated real-world evidence for vaccine effectiveness monitoring should be pursued to clarify roles and responsibilities, set up expectations, and decide the future environment for vaccine monitoring in Europe. In parallel, the driving factors behind PPP hesitancy should be studied.

Exclusive breastfeeding and women's psychological well-being during the first wave of COVID-19 pandemic in Italy.

Background: At the onset of the COVID-19 pandemic, support for breastfeeding was disrupted in many countries. Italy was severely impacted by the pandemic and is known to have the lowest exclusive breastfeeding rate of all European countries. Considering the inverse association between anxiety and breastfeeding, maternal concerns about the COVID-19 emergency could reduce breastfeeding rates. The aim of the study is to explore the association between infant feeding practices and maternal COVID-19 concerns. Methods: This paper is a secondary analysis of the cross-sectional study COVID-ASSESS conducted in Italy in 2020. The original survey was administered in two phases: during the first lockdown and during the reopening. The survey included five sections: socio-demographic, medical history, concerns about the COVID-19 pandemic, infant feeding practices and psychometric evaluation. Participants were considered eligible for the post-hoc analyses if they were exclusively breastfeeding or they were feeding with infant formula (either alone or with breastfeeding) at the time of the interview. Results: Between phase 1 and phase 2 there was a decrease in anxiety and concerns about the danger of COVID-19 to general health, except for concerns about their baby's health. Women using formula were more concerned about all the health topics investigated. Moreover, they showed higher levels of stress, state anxiety, somatization and PTSD symptoms. Conclusion: Breastfeeding during the first pandemic lockdown in Italy seems to have been an independent factor associated with lower anxiety about COVID-19, fewer psychopathological symptoms, and a positive experience of infant feeding.

Multicountry study protocol of COCOON: COntinuing Care in COVID-19 Outbreak global survey of New, expectant, and bereaved parent experiences.

INTRODUCTION: Globally, the COVID-19 pandemic has significantly disrupted the provision of healthcare and efficiency of healthcare systems and is likely to have profound implications for pregnant and postpartum women and their families including those who experience the tragedy of stillbirth or neonatal death. This study aims to understand the psychosocial impact of COVID-19 and the experiences of parents who have accessed maternity, neonatal and bereavement care services during this time. METHODS AND ANALYSIS: An international, cross-sectional, online and/or telephone-based/face-to-face survey is being administered across 15 countries and available in 11 languages. New, expectant and bereaved parents during the COVID-19 pandemic will be recruited. Validated psychometric scales will be used to measure psychosocial well-being. Data will be analysed descriptively and by assessing multivariable associations of the outcomes with explanatory factors. In seven of these countries, bereaved parents will be recruited to a nested, qualitative interview study. The data will be analysed using a grounded theory analysis (for each country) and thematic framework analysis (for intercountry comparison) to gain further insights into their experiences. ETHICS AND DISSEMINATION: Ethics approval for the multicountry online survey, COCOON, has been granted by the Mater Misericordiae Human Research Ethics Committee in Australia (reference number: AM/MML/63526). Ethics approval for the nested qualitative interview study, PUDDLES, has been granted by the King's College London Biomedical & Health Sciences, Dentistry, Medicine and Natural & Mathematical Sciences Research Ethics Subcommittee (reference number: HR-19/20-19455) in the UK. Local ethics committee approvals were granted in participating countries where required. Results of the study will be published in international peer-reviewed journals and through parent support organisations. Findings will contribute to our understanding of delivering maternity care services, particularly bereavement care, in high-income, lower middle-income and low-income countries during this or future health crises.

Attitudes and Perceptions of University Students in Healthcare Settings towards Vaccines and Vaccinations Strategies during the COVID-19 Pandemic Period in Italy.

BACKGROUND: Healthcare students that refuse to get vaccinated may expose themselves and their patients to several vaccine-preventable diseases, especially during outbreaks or at peak epidemic activity, becoming a threat to themselves and their patients. This study aimed to assess their attitudes towards and perception of vaccines and vaccination. METHODS: An anonymous questionnaire was shared with medical students, pharmacy students and medical residents in Hygiene and Preventive Medicine at the University of Florence (Italy), in February 2021. The questionnaire contained 39 questions with open, multi-choice, yes-no, Likert scale answers. A Vaccine Hesitancy Index (VHI) was then calculated. A descriptive statistical analysis was performed. RESULTS: A total of 473 students participated in this study. All students were in favour of vaccination (99.2%) but a relatively low number of participants judged their level of knowledge about vaccinations as "good" (21.8%) or "excellent" (0.6%). About half of students declared that they are not adequately trained during their academic courses. The VHI showed low levels of vaccine hesitancy (mean ± SD 0.38 ± 0.16); moreover, the students were willing to get vaccinated against SARS-CoV-2 when recommended (88.2%) and thought that these vaccines are generally safe. Few students considered the development of SARS-CoV-2 vaccines (13.1%) and the procedures for evaluating clinical trials for marketing authorisation of these vaccines (12.9%) too fast to guarantee their efficacy and safety. CONCLUSIONS: Since vaccination and vaccine hesitancy and acceptance topics are being paid increasing attention by the population, new strategies to increase future healthcare professionals' willingness to promote vaccination and get vaccinated, as well as knowledge on vaccines and vaccination, will be of the utmost importance to fight vaccine preventable diseases.

Knowledge of University Students in Health Care Settings on Vaccines and Vaccinations Strategies: Impact Evaluation of a Specific Educational Training Course during the COVID-19 Pandemic Period in Italy.

BACKGROUND: Training future healthcare professionals on vaccination through specific courses is important to properly promote active immunization among the general population and to fight fake news and false beliefs on vaccinations. The aim of the study was to assess the impact of an elective course about vaccinations on the knowledge of medical students, pharmacy students, and medical resident in Hygiene and Preventive Medicine in Italy. METHODS: The participants were asked to complete an anonymous questionnaire before and after an elective teaching activity (ETA) on vaccination. The two questionnaires contained the same 30 questions and focused on different aspects of vaccines and vaccination. The students who had attended the seminar were allowed to fulfil the post-lecture questionnaire. Both descriptive and inferential analysis were performed on the results; in particular, Student's t-test for independent samples was used to compare the total score obtained before and after attending the ETA. RESULTS: A total of 449 students participated in the ETA. Overall, the participation in the ETA allowed them to significantly improve their final score (+27.28%, p < 0.001). Good results were obtained even when comparing the three groups (medical students, pharmacy students and medical residents) separately. Females improved more than males, especially among pharmacy students. DISCUSSION: The present study highlights the importance and the impact that extracurricular activities can have in improving knowledge about vaccinations. With vaccination and vaccine hesitancy and acceptance topics with increasing attention paid by the population, especially after the COVID-19 pandemic, it is fundamental to develop new strategies to increase future healthcare professionals' knowledge about vaccinations.

Pharmacovigilance and Pharmacoepidemiology as a Guarantee of Patient Safety: The Role of the Clinical Pharmacologist

Recent years, particularly the COVID-19 pandemic, can be considered a turning point for pharmacovigilance and pharmacoepidemiology in terms of their role in drug safety and drug utilisation monitoring in clinical practice [...]

COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety.

To date, four vaccines have been authorised for emergency use and under conditional approval by the European Medicines Agency to prevent COVID-19: Comirnaty, COVID-19 Vaccine Janssen, Spikevax (previously COVID-19 Vaccine Moderna) and Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Although the benefit-risk profile of these vaccines was proven to be largely favourable in the general population, evidence in special cohorts initially excluded from the pivotal trials, such as pregnant and breastfeeding women, children/adolescents, immunocompromised people and persons with a history of allergy or previous SARS-CoV-2 infection, is still limited. In this narrative review, we critically overview pre- and post-marketing evidence on the potential benefits and risks of marketed COVID-19 vaccines in the above-mentioned special cohorts. In addition, we summarise the recommendations of the scientific societies and regulatory agencies about COVID-19 primary prevention in the same vaccinee categories.

Exposures and suspected intoxications during SARS-CoV-2 pandemic: preliminary results from an Italian poison control centre.

Data on cleaner and disinfectant exposure and misuse-related acute intoxications in Italy during SARS-CoV-2 pandemic are still lacking. The aim of the present study was to analyse and describe cleaner and disinfectant-related intoxications during SARS-CoV-2 pandemic in an Italian poison control centre. Data were obtained from the toxicological consultations requested to the Toxicology Unit and Poison Centre, Careggi University Hospital, Florence (Italy). We compared data from January 1st to April 30th of 2019 and 2020. Data concerning probable or acute intoxication from any causative agent in the general population (all age groups), from private individuals or from Regional and National health structures, were included in the analysis. A toxicological evaluation was also performed to calculate the Poisoning Severity Score.In 2019, 451 phone counselling sessions were performed and compared to a total of 410 calls received during the same period of 2020. In both periods, the majority of events occurred in paediatric (0-17 years) and adult (18-65 years) patients, who were mainly exposed to one toxic agent, and intoxications took place principally at home due to domestic accidents. The oral route of intoxication was the most frequently observed one, followed by inhalation of toxic agents, which increased by 4.7% in 2020. In 2020, sanitizers and cleaners were reported in 21.6% of cases compared to 12.5% in 2019. This is the first study describing cleaner and disinfectant-related intoxications in Italy. Our results suggested a possible misuse of these products during the SARS-CoV-2 pandemic, underling the effects of home isolation on mental health and unintentional toxic exposures.

Adverse drug reactions in SARS-CoV-2 hospitalised patients: a case-series with a focus on drug-drug interactions.

Due to the need of early and emergency effective treatments for COVID-19, less attention may have been paid to their safety during the global emergency. In addition, characteristics of drug-drug interaction (DDI)-related adverse drug reactions (ADRs) in COVID-19 patients have not yet been studied in depth. The aim of the present case-series study is to describe clinical and pharmacological characteristics of SARS-CoV-2 hospitalised patients, focusing on ADRs, particularly those related to DDIs. We evaluated all reports of COVID-19 medication-related ADRs collected within the COVID-19 Units of Careggi University Hospital, Florence (Italy), between January 1st and 31st May 2020. Information regarding COVID-19 medications, patients' demographic and clinical characteristics, concomitant drugs, ADRs description and outcome, were collected. Each case was evaluated for the causality assessment and to identify the presence of DDIs. During the study period, 23 Caucasian patients (56.5% males, mean age 76.1 years) experienced one or more ADRs. The majority of them were exposed to polypharmacy and 17.4% presented comorbidities. ADRs were referred to cardiovascular, psychiatric and gastrointestinal disorders. The most frequently reported preferred term was QT prolongation (mean QT interval 496.1 ms). ADRs improved or resolved completely in 60.8% of cases. For all patients, a case-by-case evaluation revealed the presence of one or more DDIs, especially those related to pharmacokinetic interactions. Despite the small number of patients, our evidence underline the clinical burden of DDIs in SARS-CoV-2 hospitalised patients and the risk of unexpected and uncommon psychiatric ADRs.

Previous psychopathology predicted severe COVID-19 concern, anxiety, and PTSD symptoms in pregnant women during "lockdown" in Italy.

Italy was the first COVID-19 pandemic epicenter among European countries and established a period of full "lockdown", consisting of travel bans, mandatory staying at home, and temporary closure of nonessential businesses. Similar measures are known risk factors for psychological disturbances in the general population; still, little is known about their impact on pregnant women's mental health during COVID-19 pandemic. The cross-sectional, web-based, national survey "COVID-19 related Anxiety and StreSs in prEgnancy, poSt-partum and breaStfeeding" (COVID-ASSESS) was conducted during the first month of full "lockdown" in Italy. Participants were recruited via social networks with a snowball technique. The questionnaire was specifically developed to examine COVID-19 concerns and included the psychometric tests National Stressful Events Survey (NSESSS) for posttraumatic stress disorder (PTSD) and State-Trait Anxiety Inventory. A multivariable logistic regression model was fitted to explore the association of the concern, anxiety and PTSD symptoms with age, gestational weeks, parity, days of "lockdown", assisted reproductive technology use, psychopathological history, and previous perinatal losses. Out of 1015 pregnant women reached, 737 (72.6%) fully answered the questionnaire; no woman reported a COVID-19 infection. Median age was 34.4 years [quartiles 31.7, 37.2], median days in "lockdown" were 13.1 [11.0, 17.0], median gestational weeks were 27.8 [19.8, 34.0]. Clinically significant PTSD symptoms were present in 75 women (10.2%, NSESSS cutoff 24) and clinically significant anxiety symptoms were present in 160 women (21.7%, STAI-Y1 cutoff 50). Women were particularly worried about the health of their baby and of their elderly relatives, as well as of the possible impact of pandemic in the future of society. Previous anxiety predicted higher concern and PTSD symptoms; previous depression and anxiety were independently associated with current PTSD symptoms.

The COVID-ASSESS dataset - COVID19 related anxiety and stress in prEgnancy, poSt-partum and breaStfeeding during lockdown in Italy.

The COVID-ASSESS questionnaire (COVID-19 related Anxiety and StreSs in prEgnancy, poSt-partum and breaStfeeding) was developed and distributed by CiaoLapo Foundation, an Italian charity for healthy pregnancy and perinatal loss support. Data were collected during phase 1 and phase 2 of COVID-19 lockdown in Italy (March, April and May 2020). The final dataset consists of 2448 women, of whom 1307 during pregnancy and 1141 women during post-partum or breastfeeding period. Variables collected for each subject are: sociodemographic and clinical information (previous losses, history of psychological disorders), birth expectations before and after COVID-19, concerns regarding pandemic consequences, perception of media and health professionals' information and communication on COVID-19, psychopathological assessment (anxiety, post-traumatic stress and general psychopathology).

Pregnant women voice their concerns and birth expectations during the COVID-19 pandemic in Italy.

BACKGROUND: In March 2020, COVID-19 was declared to be a pandemic. While data suggests that COVID-19 is not associated with significant adverse health outcomes for pregnant women and newborns, the psychological impact on pregnant women is likely to be high. AIM: The aim was to explore the psychological impact of the COVID-19 pandemic on Italian pregnant women, especially regarding concerns and birth expectations. METHODS: A cross-sectional online survey of pregnant women in Italy was conducted. Responses were analysed for all women and segregated into two groups depending on previous experience of pregnancy loss. Analysis of open text responses examined expectations and concerns before and after the onset of the pandemic. FINDINGS: Two hundred pregnant women responded to the first wave of the survey. Most (n=157, 78.5%) had other children and 100 (50.0%) had a previous history of perinatal loss. 'Joy' was the most prevalent emotion expressed before COVID-19 (126, 63.0% before vs 34, 17.0% after; p<0.05); fear was the most prevalent after (15, 7.5% before vs 98, 49.0% after; p<0.05). Positive constructs were prevalent before COVID-19, while negative ones were dominant after (p<0.05). Across the country, women were concerned about COVID-19 and a history of psychological disorders was significantly associated with higher concerns (p<0.05). A previous pregnancy loss did not influence women's concerns. CONCLUSIONS: Women's expectations and concerns regarding childbirth changed significantly as a result of the COVID-19 pandemic in Italy. Women with a history of psychological disorders need particular attention as they seem to experience higher levels of concern.